Join the Central Indiana Chapter for a virtual lunchtime meeting on June 10, 2026. Our special guest speaker will be Dr. Frank Rockhold who will be speaking on the fundamental aspects of Data Monitoring Committees.
title: Data Monitoring Committees in Clinical Trials: Realities and Myths
speaker: Frank W. Rockhold, Ph.D.
Professor of Biostatistics, Duke University School of Medicine
date: Wednesday, June 10, 2026
time: Noon - 1:00 pm ET
cost: FREE
register: register on Zoom
Abstract
Over the past seven decades, the randomized clinical trial (RCT) has evolved to serve as the benchmark for the evaluation of new pharmaceuticals, medical devices, procedures, and behavioral interventions. Correspondingly, the role of the Independent Data Monitoring Committee (IDMC) as proposed in ICH E9, also known as the Data and Safety Monitoring Board (DSMB), which was outlined in the Declaration of Helsinki and first formally recommended by the Greenberg Report in 1967, has similarly advanced. IDMCs are responsible for reviewing the complete body of evidence—including emerging unblinded safety (risk) and efficacy (benefit) data—and may recommend modifications to the RCT or early termination when there is evidence of harm or compelling changes to benefit-risk. The IDMC also has the responsibility to monitor and ensure trial integrity on behalf of the patients. The utilization of IDMCs continues to rise. Alongside this increased adoption over the last five to six decades, there has been an expansion in the use of independent statistical reporting groups (ISRGs), which supply interim reports for IDMC review. Despite substantial growth, there remains a notable shortage of clinical and statistical scientists with the necessary training and expertise to serve as members of IDMCs or provide ISRG-type support.
This presentation will outline fundamental aspects of DMC operations, including typical responsibilities, committee composition, meeting structure, operational policies, and current issues—both emerging and controversial—in data monitoring. The objective of this discussion is to enhance understanding of DMC responsibilities and address the ongoing challenges and misunderstandings within the clinical trials community.
Speaker
Frank Rockhold is Professor of Biostatistics and Bioinformatics at Duke University School of Medical. His 50+ year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance. Dr. Rockhold is internationally recognized for his expertise in clinical trial design, safety and pharmacovigilance, public data disclosure, and scientific transparency. He has presented at FDA Advisory Committee meetings, Japanese and European regulatory agencies, National Academy of Medicine, and the White House Office of Technology and Science. He is formerly an advisor to the Patient Centered Outcomes Research Institute as part of the Affordable Care Act.
Dr. Rockhold is past President of the Society for Clinical trials, past Chairman of the board for CDISC and is currently Chairman of the Board of the Frontier Research Foundation and an advisor to EMA. He is coauthor of the ICH (International Council for Harmonization) E9 (Biostatistics) and E10 (Control Groups) guidelines and he has more than 250 publications in peer-reviewed scientific journals and more than 350 presentations and seminars at Scientific Symposia. Frank has served on and chaired more than 100 independent data monitoring committees.
Dr. Rockhold holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. He is an Elected Fellow of the American Statistical Association, the Society for Clinical Trials, and the Royal Statistical Society. He is an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.